. . . The Secretary specifically directed that the Final EIR [Environmental Impact Report] address only four issues: (1) “discuss the design features that the biocontainment building will employ to enhance safety,” (2) “document how the facility would meet any applicable state and federal regulations regarding safety of the facility,” (3) “evaluate a ‘worst case’ safety event involving the loss of the physical integrity of the containment systems,” and (4) “address safety considerations related to any transport of potentially hazardous biological agents to and from the Biocontainment facility.” In providing this guidance, the Secretary failed to focus on the difference in risk posed by pathogens which can be spread through the air and may be fatal if inhaled but are not contagious (such as anthrax or, more precisely, its infectious agent—bacillus anthracis), versus those pathogens which are infectious and can be spread through person-to-person contact, such as:
Smallpox, which can be spread by “direct and fairly prolonged face-to-face contact” or “direct contact with infected bodily fluids or contaminated objects, such as bedding or clothing,”
Severe Acute Respiratory Syndrome, known as SARS, which can be spread “through respiratory droplets,”
Ebola hemorrhagic fever, which can be spread “through direct contact with infected blood secretions, organs or semen.”
Since the “worst case safety event” was limited to “the loss of the physical integrity of the containment systems,” University Associates reasonably understood that the focus should be on pathogens that can be spread by airborne inhalation if the ventilation containment system at the BSL-4 laboratory were to fail, and therefore provided the scenario involving the dropped vial of purified anthrax inside the laboratory.
There were two substantial failures in the risk assessment that arose from limiting the “worst case safety event” to a failure of the ventilation containment system. First, no “worst case safety event” was analyzed regarding any release of a contagious disease from the laboratory, even though such a release potentially may occur, not from a complete failure of the ventilation containment system, but simply from a laboratory staff member becoming infected with the infectious pathogen. The risk of such an infection, while small, cannot be characterized as nonexistent.
Appendix 4 of the Final EIR contains two reports prepared by Karl M. Johnson, M.D. on October 15, 2003. The first, entitled “Biosafety at National Institute of Allergy and Infectious Disease: 1982-2003,” examines the number of accidental exposures to infectious agents during this period at BSL-2 and BSL-3 laboratories operated by the National Institute in three locations—Bethesda and Rockville, Maryland, and Hamilton, Montana. Dr. Johnson found one clinical infection, four silent infections, and 24 other accidents which did not lead to infections in more than three million hours of working with these organisms. While Dr. Johnson justly concludes that the safety record for these laboratories is “outstanding” and specifically notes that “[n]o agent has escaped from any laboratory to cause infection in adjacent civilian communities,” his report demonstrates that there is a small, but significant, risk of infections and accidental exposures over the life of these facilities. Dr. Johnson’s second report, entitled “Biosafety at BSL-4: More than 20 Years Experience at Three Major Facilities,” examined the number of laboratory accidents at three BSL-4 laboratories—Fort Detrick, Maryland, the CDC laboratory in Atlanta, and a laboratory in Johannesburg, South Africa operated by the South African National Institute for Communicable Diseases. Dr. Johnson found that, at Fort Detrick, in the early years of the laboratory, an unspecified number of “invasive accidents resulted in treatment with human plasma containing specific antibodies to virus in question, as well as confinement in an isolation suite in one building….” Two invasive accidents were of the greatest concern, one in which a staff member’s finger was accidentally punctured with a needle on a syringe loaded with the Lassa virus and another in which a bone fragment of a monkey infected with the Junin virus punctured a staff member’s finger. Fortunately, no infection occurred in either incident. At the CDC facility, various laboratory accidents were identified, none of which resulted in an infection. Among these accidents were: a rodent infected with Hantavirus bit a staff member; a needle pricked a worker who was setting up an inoculation with a mouse-adapted Ebola virus; and “multiple events over the years of outer gloves or suits developing tears or holes detected during work.” At the Johannesburg laboratory, Dr. Johnson learned of a bat bite through double gloves, which did not produce an infection, and “multiple other accidents,” during which “[t]hose exposed are monitored closely for 21 days, during which time they are not permitted to leave town—as are all employees after their last day of work inside BSL-4 space.” No infections were reported from these accidents. Here, too, Dr. Johnson could justly conclude that no clinical infections had occurred at these facilities despite nearly half a million hours of working with these organisms, and that no infectious agent had escaped into a neighboring community. However, Dr. Johnson does not negate the possibility of infection to either laboratory workers or the outside community. Rather, he states, “The zero numerator of infections in these three laboratories and the huge denominator of exposure hours make it impossible to provide a number for ‘risk of infection’ to either laboratory workers or outside communities. Nevertheless, that number must be small.”
Dr. Johnson did not identify any instance of intentional infection by a laboratory employee, such as a laboratory worker who intended to infect himself or a co-worker, or of the intentional removal of a pathogen from the laboratory to commit extortion or provide to a terrorist organization. This risk, too, is surely small but, equally surely, the risk must be recognized to exist. To be sure, the Final EIR observes that background and security checks will be conducted on all employees before being assigned to the Biolab. However, all CIA and FBI agents are subject to background and security checks as well, perhaps more intensive than any contemplated by NIH, but there are at least two documented instances in the past two decades of a CIA agent (Aldrich Ames) and FBI agent (Robert Hanssen) each with compartmentalized top secret clearances, providing classified secrets to the then-Soviet Union that risked (and probably cost) the lives of various confidential informants. If the CIA and FBI, with their expertise in background checks, cannot ensure that none of
their carefully selected agents will betray their trust, there is no good reason to assume that University Associates need not fear this risk.
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In short, the Final EIR demonstrated that there was a small, but significant, risk of a laboratory accident that could result in the infection of a laboratory worker with a contagious disease, but the Final EIR did not contain any “worst case” scenario that explored the potential consequences of such an accident. Nor did it contain any “worst case” scenario that explored the potential consequences of the release of a contagious pathogen arising from a suicidal, criminal, or terrorist act.
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. . .Any reasonable evaluation of a risk requires an understanding of the probability of the risk occurring over the life of the Project and the magnitude of harm that could arise if it were to occur. From the Final EIR, the agencies could evaluate the probability of an accidental or malevolent release of a contagious pathogen and recognize it to be small, but the Final EIR did not provide any guidance as to the magnitude of harm that could result if that small risk were sadly to occur. Since, as noted earlier, “[a]ny finding required by [Section 61] shall be limited to those matters which are within the scope of the environmental impact report,” G.L. c. 30 §62A, the absence of this information regarding the potential environmental impact meant that it could not be addressed in the Section 61 finding. Even worse, the Final EIR permitted the agencies to act upon the belief that even the “worst case safety event” posed only a negligible risk of public harm. Therefore, the absence of any “worst case” scenario involving the accidental or malevolent release of a contagious disease-causing organism meant that the Final EIR failed to inform the relevant public agencies making financial and permitting decisions regarding the Project of the potential for catastrophic harm posed by the Project. To be sure, the small risk of even catastrophic harm does not suggest that any public agency should kill the Project, especially when, as here, the Project itself will conduct research designed to combat bioterrorism. But it is necessary that a public agency considering such a Project come to grips with the true risks posed by the Project and not be lulled by the Final EIR into ignoring the small possibility of enormous public harm.
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F. FEDERAL PREPAREDNESS
PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002, Pub. L. No. 107-188.
Title I—NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES
Subtitle A—National Preparedness and Response Planning, Coordinating, and Reporting
“Sec. 2801. NATIONAL PREPAREDNESS PLAN.
“(a) In General.—
“(1) Preparedness and response regarding public health emergencies.—The Secretary shall further develop and implement a coordinated strategy, building upon the core public health capabilities established pursuant to section 319A, for carrying out health-related activities to prepare for and respond effectively to bioterrorism and other public health emergencies, including the preparation of a plan under this section. The Secretary shall periodically thereafter review and, as appropriate, revise the plan.
“(2) National approach.—In carrying out paragraph (1), the Secretary shall collaborate with the States toward the goal of ensuring that the activities of the Secretary regarding bioterrorism and other public health emergencies are coordinated with activities of the States, including local governments.
“(3) Evaluation of progress.—The plan under paragraph (1) shall provide for specific benchmarks and outcome measures for evaluating the progress of the Secretary and the States, including local governments, with respect to the plan under paragraph (1), including progress toward achieving the goals specified in subsection (b).
“(b) Preparedness Goals.—The plan under subsection (a) should include provisions in furtherance of the following:
“(1) Providing effective assistance to State and local governments in the event of bioterrorism or other public health emergency.
“(2) Ensuring that State and local governments have appropriate capacity to detect and respond effectively to such emergencies, including capacities for the following:
“(A) Effective public health surveillance and reporting mechanisms at the State and local levels.
“(B) Appropriate laboratory readiness.
“(C) Properly trained and equipped emergency response, public health, and medical personnel.
“(D) Health and safety protection of workers responding to such an emergency.
“(E) Public health agencies that are prepared to coordinate health services (including mental health services) during and after such emergencies.
“(F) Participation in communications networks that can effectively disseminate relevant information in a timely and secure manner to appropriate public and private entities and to the public.
“(3) Developing and maintaining medical countermeasures (such as drugs, vaccines and other biological products, medical devices, and other supplies) against biological agents and toxins that may be involved in such emergencies.
“(4) Ensuring coordination and minimizing duplication of Federal, State, and local planning, preparedness, and response activities, including during the investigation of a suspicious disease outbreak or other potential public health emergency.
“(5) Enhancing the readiness of hospitals and other health care facilities to respond effectively to such emergencies.
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DEPARTMENT OF HOMELAND SECURITY, NATIONAL RESPONSE PLAN (December 2004)
Introduction The Nation’s domestic incident management landscape changed dramatically following the terrorist attacks of September 11, 2001. Today’s threat environment includes not only the traditional spectrum of manmade and natural hazards—wildland and urban fires, floods, oil spills, hazardous materials releases, transportation accidents, earthquakes, hurricanes, tornadoes, pandemics, and disruptions to the Nation’s energy and information technology infrastructure—but also the deadly and devastating terrorist arsenal of chemical, biological, radiological, nuclear, and high-yield explosive weapons.
These complex and emerging 21st century threats and hazards demand a unified and coordinated national approach to domestic incident management. The National Strategy for Homeland Security; Homeland Security Act of 2002; and Homeland Security Presidential Directive-5 (HSPD-5), Management of Domestic Incidents, establish clear objectives for a concerted national effort to prevent terrorist attacks within the United States; reduce America’s vulnerability to terrorism, major disasters, and other emergencies; and minimize the damage and recover from attacks, major disasters, and other emergencies that occur.
Development and Implementation of a National Response Plan Achieving these homeland security objectives is a challenge requiring bold steps and adjustments to established structures, processes, and protocols. An important initiative called for in the above documents is the development and implementation of a National Response Plan (NRP), predicated on a new National Incident Management System (NIMS), that aligns the patchwork of Federal special-purpose incident management and emergency response plans into an effective and efficient structure. Together, the NRP and the NIMS integrate the capabilities and resources of various governmental jurisdictions, incident management and emergency response disciplines, nongovernmental organizations (NGOs), and the private sector into a cohesive, coordinated, and seamless national framework for domestic incident management.
The NRP, using the NIMS, is an all-hazards plan that provides the structure and mechanisms for national-level policy and operational coordination for domestic incident management….
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Purpose The purpose of the NRP is to establish a comprehensive, national, all-hazards approach to domestic incident management across a spectrum of activities including prevention, preparedness, response, and recovery.
The NRP incorporates best practices and procedures from various incident management disciplines—homeland security, emergency management, law enforcement, firefighting, hazardous materials response, public works, public health, emergency medical services, and responder and recovery worker health and safety—and integrates them into a unified coordinating structure.
The NRP provides the framework for Federal interaction with State, local, and tribal governments; the private sector; and NGOs in the context of domestic incident prevention, preparedness, response, and recovery activities. It describes capabilities and resources and establishes responsibilities, operational processes, and protocols to help protect the Nation from terrorist attacks and other natural and manmade hazards; save lives; protect public health, safety, property, and the environment; and reduce adverse psychological consequences and disruptions….
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Incidents of National Significance As the principal Federal official for domestic incident management, the Secretary of Homeland Security declares Incidents of National Significance…and provides coordination for Federal operations and/or resources, establishes reporting requirements, and conducts ongoing communications with Federal, State, local, tribal, private-sector, and nongovernmental organizations to maintain situational awareness, analyze threats, assess national implications of threat and operational response activities, and coordinate threat or incident response activities.
The NRP bases the definition of Incidents of National Significance on situations related to the following four criteria…:
A Federal department or agency acting under its own authority has requested the assistance of the Secretary of Homeland Security.
The resources of State and local authorities are overwhelmed and Federal assistance has been requested by the appropriate State and local authorities. Examples include:
Major disasters or emergencies as defined under the Stafford Act; and
More than one Federal department or agency has become substantially involved in responding to an incident. Examples include:
Credible threats, indications or warnings of imminent terrorist attack, or acts of terrorism directed domestically against the people, property, environment, or political or legal institutions of the United States or its territories or possessions; and
Threats or incidents related to high-profile, large-scale events that present high-probability targets such as National Special Security Events (NSSEs) and other special events as determined by the Secretary of Homeland Security, in coordination with other Federal departments and agencies.
The Secretary of Homeland Security has been directed to assume responsibility for managing a domestic incident by the President.
Incident Management Activities
…Examples of incident management actions from a national perspective include:
Assessing trends that point to potential terrorist activity;
Elevating the national Homeland Security Advisory System (HSAS) alert condition and coordinating protective measures across jurisdictions;
Increasing countermeasures such as inspections, surveillance, security, counterintelligence, and infrastructure protection;
Conducting public health surveillance and assessment processes and, where appropriate, conducting a wide range of prevention measures to include, but not be limited to, immunizations;
Providing immediate and long-term public health and medical response assets;
Coordinating Federal support to State, local, and tribal authorities in the aftermath of an incident;
Providing strategies for coordination of Federal resources required to handle subsequent events;
Restoring public confidence after a terrorist attack; and
Enabling immediate recovery activities, as well as addressing long-term consequences in the impacted area.
GEORGE J. ANNAS,
THE STATUE OF SECURITY: HUMAN RIGHTS AND POST-9/11 EPIDEMICS
38 J. Health Law 319 (2005)
Our enemies are innovative and resourceful, and so are we. They never stop thinking about new ways to harm our country and our people, and neither do we.
President George W. Bush on signing the Defense Appropriations Act, August 5, 2004
Immediately after 9/11 the U.S. government closed the Statue of Liberty to the public. It took almost three years to reopen Liberty Island, just in time for the Republican National Convention. The public can again visit, but little is the same. Those wishing to take the ferry to the island, for example, must submit to airport-like screening, as well as bag checks, including bomb-sniffing dogs, upon arrival. And on the boat trip, the National Park Service has a new recorded “welcome” which asserts that although historically the Statue of Liberty symbolized freedom, it is now “a symbol of America’s freedom, safety, and security.” Similar screening is also required to view the Liberty Bell in Philadelphia. We have not yet renamed the Statue of Liberty, the “Statue of Security”; or the Liberty Bell, the “Safety Bell,” but safety and security have been consistently promoted as at least as important as liberty, and often more important, since 9/11.
The next stop after Liberty Island is Ellis Island, the site of screening for more than 2 million immigrants to America in the early 20th century. The most rigorous part of screening immigrants involved federal uniformed public health service physicians whose main duty was to prevent immigrants with contagious diseases from entering the country. Few federal public health officials other than the Surgeon General any longer where military uniforms, and most public health activities now are done under state or local jurisdiction. But 9/11 has affected public health as well, as public health has been called upon to prepare the nation for a “bioterrorist attack” utilizing lethal disease agents, like smallpox or anthrax. Many public health officials hope that public health can take advantage of the new funding available for terrorism preparedness, and not only do its part in national security, but also make “dual use” of the funding to help it fulfill its core missions of protecting the publics’ health and preparing for “natural” epidemics.
September 11 was an event, not an epidemic, but the U.S. reacted to it as if it portends an actual epidemic of terrorist attacks against us. In this way, September 11 has been viewed by many in the public health community as a signal of a coming pandemic: akin to the rise of SARS in China, or a novel form of bird flu in Asia. (1) And public health has been asked to prepare for both natural and terrorist-induced epidemics simultaneously. Does 9/11 mean we must make fundamental changes in public health practice regarding epidemic control and revert to 19th century Ellis Island-type quarantine and forced treatment? Must we trade off human rights and civil liberties for increased safety and security? These are important and complex questions. In this article I argue that the answer to both of these questions is no, and that the movement in public health toward the adoption of a modern health and human rights ethical framework begun before 9/11 should continue.
Osama bin Laden and his homicidal Qaeda followers present a real danger to Americans, and the US should bring them to justice for their crimes. The U.S. is more vulnerable to terrorist attacks than we had believed; and we should strengthen our defenses. But we should not undermine our lives and our values by overreacting to the threat of terrorism. Preserving a human rights framework in the war on terrorists both preserves core American values, and makes it more likely that we will prevail in the long run. Ignoring or marginalizing human and constitutional rights, and treating Americans themselves as suspects or actual enemies is counterproductive and dangerous in itself—a conclusion I will support in this article with specific post-9/ll examples, such as public health preparedness plans for mass smallpox vaccination, the experiences of public health in the SARS epidemic, the enactment of new state public health vaccination and quarantine laws, and the use of torture on terrorist suspects and prisoners of war. Public health professionals are the “good guys” and rightly want to protect the publics’ health. But the world has changed since the early 19th century, and reliance on coercion rather than education is no longer either legally justifiable or likely to be effective. In this regard, what might be labeled “public health fundamentalism,” is as dangerous to the health and safety of Americans as Islamic religious fundamentalism.
The language of human rights also has the great advantage of being universal and thus global. Neither the fight against terrorists, nor the fight against epidemics, can be successfully waged on a local, state, or even national level alone: both can easily cross national boundaries and both can only be effectively confronted by a global, cooperative, strategy. “Safety first” is a good thought, as is the Hippocratic injunction, “first, do no harm”; but neither safety nor inaction are ends in themselves, but only means to promote health and human rights. Sacrificing human rights for safety is almost never necessary and almost always counterproductive in a free society. Benjamin Franklin went further in expressing an American thought from “the land of the free and the home of the brave,” saying, “Those who would give up an essential liberty to purchase temporary security deserve neither liberty nor security.” ***